Background: Current clinical definitions of diabetes require repeated blood work to confirm elevated levels of glucose or hemoglobin A1c (HbA1c) to reduce the possibility of a false-positive diagnosis. Whether 2 different tests from a single blood sample provide adequate confirmation is uncertain. Objective: To examine the prognostic performance of a single-sample confirmatory definition of undiagnosed diabetes. Design: Prospective cohort study. Setting: The ARIC (Atherosclerosis Risk in Communities) study. Participants: 13 346 ARIC participants (12 268 without diagnosed diabetes) with 25 years of follow-up for incident diabetes, cardiovascular outcomes, kidney disease, and mortality. Measurements: Confirmed undiagnosed diabetes was defined as elevated levels of fasting glucose (≥7.0 mmol/L [≥126 mg/dL]) and HbA1c (≥6.5%) from a single blood sample. Results: Among 12 268 participants without diagnosed diabetes, 978 had elevated levels of fasting glucose or HbA1c at baseline (1990 to 1992). Among these, 39% had both (confirmed undiagnosed diabetes), whereas 61% had only 1 elevated measure (unconfirmed undiagnosed diabetes). The confirmatory definition had moderate sensitivity (54.9%) but high specificity (98.1%) for identification of diabetes cases diagnosed during the first 5 years of follow-up, with specificity increasing to 99.6% by 15 years. The 15-year positive predictive value was 88.7% compared with 71.1% for unconfirmed cases. Confirmed undiagnosed diabetes was significantly associated with cardiovascular and kidney disease and mortality, with stronger associations than unconfirmed diabetes. Limitation: Lack of repeated measurements of fasting glucose and HbA1c. Conclusion: A single-sample confirmatory definition of diabetes had a high positive predictive value for subsequent diagnosis and was strongly associated with clinical end points. Our results support the clinical utility of using a combination of elevated fasting glucose and HbA1c levels from a single blood sample to identify undiagnosed diabetes in the population. Primary Funding Source: National Institute of Diabetes and Digestive and Kidney Diseases and National Heart, Lung, and Blood Institute.
Background: Current clinical definitions of diabetes require repeated blood work to confirm elevated levels of glucose or hemoglobin A1c (HbA1c) to reduce the possibility of a false-positive diagnosis. Whether 2 different tests from a single blood sample provide adequate confirmation is uncertain. Objective: To examine the prognostic performance of a single-sample confirmatory definition of undiagnosed diabetes. Design: Prospective cohort study. Setting: The ARIC (Atherosclerosis Risk in Communities) study. Participants: 13 346 ARIC participants (12 268 without diagnosed diabetes) with 25 years of follow-up for incident diabetes, cardiovascular outcomes, kidney disease, and mortality. Measurements: Confirmed undiagnosed diabetes was defined as elevated levels of fasting glucose (≥7.0 mmol/L [≥126 mg/dL]) and HbA1c (≥6.5%) from a single blood sample. Results: Among 12 268 participants without diagnosed diabetes, 978 had elevated levels of fasting glucose or HbA1c at baseline (1990 to 1992). Among these, 39% had both (confirmed undiagnosed diabetes), whereas 61% had only 1 elevated measure (unconfirmed undiagnosed diabetes). The confirmatory definition had moderate sensitivity (54.9%) but high specificity (98.1%) for identification of diabetes cases diagnosed during the first 5 years of follow-up, with specificity increasing to 99.6% by 15 years. The 15-year positive predictive value was 88.7% compared with 71.1% for unconfirmed cases. Confirmed undiagnosed diabetes was significantly associated with cardiovascular and kidney disease and mortality, with stronger associations than unconfirmed diabetes. Limitation: Lack of repeated measurements of fasting glucose and HbA1c. Conclusion: A single-sample confirmatory definition of diabetes had a high positive predictive value for subsequent diagnosis and was strongly associated with clinical end points. Our results support the clinical utility of using a combination of elevated fasting glucose and HbA1c levels from a single blood sample to identify undiagnosed diabetes in the population. Primary Funding Source: National Institute of Diabetes and Digestive and Kidney Diseases and National Heart, Lung, and Blood Institute.
Authors: Wayne D Rosamond; Patricia P Chang; Chris Baggett; Anna Johnson; Alain G Bertoni; Eyal Shahar; Anita Deswal; Gerardo Heiss; Lloyd E Chambless Journal: Circ Heart Fail Date: 2012-01-23 Impact factor: 8.790
Authors: Wayne D Rosamond; Lloyd E Chambless; Gerardo Heiss; Thomas H Mosley; Josef Coresh; Eric Whitsel; Lynne Wagenknecht; Hanyu Ni; Aaron R Folsom Journal: Circulation Date: 2012-03-15 Impact factor: 29.690
Authors: W D Rosamond; A R Folsom; L E Chambless; C H Wang; P G McGovern; G Howard; L S Copper; E Shahar Journal: Stroke Date: 1999-04 Impact factor: 7.914
Authors: Laura R Loehr; Wayne D Rosamond; Patricia P Chang; Aaron R Folsom; Lloyd E Chambless Journal: Am J Cardiol Date: 2008-02-14 Impact factor: 2.778
Authors: Morgan E Grams; Casey M Rebholz; Blaithin McMahon; Seamus Whelton; Shoshana H Ballew; Elizabeth Selvin; Lisa Wruck; Josef Coresh Journal: Am J Kidney Dis Date: 2014-04-13 Impact factor: 8.860
Authors: Stephen Colagiuri; Crystal M Y Lee; Tien Y Wong; Beverley Balkau; Jonathan E Shaw; Knut Borch-Johnsen Journal: Diabetes Care Date: 2010-10-26 Impact factor: 19.112
Authors: Elizabeth Selvin; Dan Wang; Alexandra K Lee; Richard M Bergenstal; Josef Coresh Journal: Ann Intern Med Date: 2017-10-24 Impact factor: 25.391
Authors: Michael Bergman; Muhammad Abdul-Ghani; João Sérgio Neves; Mariana P Monteiro; Jose Luiz Medina; Brenda Dorcely; Martin Buysschaert Journal: J Clin Endocrinol Metab Date: 2020-08-01 Impact factor: 5.958
Authors: Udoka Obinwa; Adriana Pérez; Ildiko Lingvay; Luigi Meneghini; Ethan A Halm; Michael E Bowen Journal: Diabetes Care Date: 2020-03-05 Impact factor: 19.112
Authors: Yiling J Cheng; Alka M Kanaya; Maria Rosario G Araneta; Sharon H Saydah; Henry S Kahn; Edward W Gregg; Wilfred Y Fujimoto; Giuseppina Imperatore Journal: JAMA Date: 2019-12-24 Impact factor: 56.272
Authors: Michael E Bowen; Julie A Schmittdiel; Jeffrey T Kullgren; Ronald T Ackermann; Matthew J O'Brien Journal: Curr Diab Rep Date: 2018-09-19 Impact factor: 4.810
Authors: Olive Tang; Kunihiro Matsushita; Josef Coresh; A Richey Sharrett; John W McEvoy; B Gwen Windham; Christie M Ballantyne; Elizabeth Selvin Journal: Diabetes Care Date: 2019-11-27 Impact factor: 17.152